Computer aided design matrix for the manufacture of dental devices

ABSTRACT

Disclosed herein are methods of manufacturing a dental device, the method comprising: obtaining a set of clinical options for the dental device from a health care provider; creating a first data set from the set of clinical options; communicating the data set to a computer aided design (CAD) software; preparing a digital design for the dental device using the CAD software; communicating the digital design to an automated milling apparatus; and automatedly milling a block of polymer to obtain the dental device. Also disclosed are dental devices manufactured by the above method. Further disclosed are methods of treating or ameliorating apnea jaw-related disorder in a patient, the method comprising obtaining a dental device manufactured by the above method and positioning the dental device over the dentition prior to sleep, whereby the mandible is advanced forward relative to the maxilla, thereby ameliorating the symptoms of sleep apnea or the jaw-related disorder.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/651,874 filed Jul. 17, 2017, by KIM et al., and entitled “ACOMPUTER AIDED DESIGN MATRIX FOR THE MANUFACTURE OF ORAL APPLIANCES,”which in turn claims priority to the U.S. Provisional Application Ser.No. 62/365,970 filed Jul. 22, 2016, by LIPTAK et al., and entitled “ACOMPUTER AIDED DESIGN MATRIX FOR THE MANUFACTURE OF ORAL APPLIANCES,”the entire disclosure of both of which, including any drawings, isincorporated by reference herein.

FIELD OF THE INVENTION

The present invention is in the field of dental devices. In particular,the present invention is in the field of a computer aided designprocedure for preparing a design and manufacturing a dental device.

BACKGROUND OF THE DISCLOSURE

The use of dental devices to treat sleep apnea is well-known in the art.These devices use several different techniques for moving the mandibleforward when the device is worn, in order to open the patient's airway,particularly during the sleep hours, and thereby reduce the occurrenceof sleep apnea. In addition, health care providers, patients, andmanufacturers have a wide variety of options in choosing the style ofthe device, the material with which the device is made, and accessoriesused with the device. These options are generally determined by thepatient anatomy, patient comfort, health care provider bias, and themanufacturing ease.

Currently, dental devices are hand-crafted artisanally to the healthcare provider's specification. Each laboratory or medical devicemanufacturer is capable of manufacturing one type, or at most, a selectfew of the options. If different styles of mandibular advancementdevices, or combination of mandibular advancement devices with othersplints utilizing the same patient data, are desired then the patient orthe health care provider must contact multiple laboratories.Accordingly, currently it is economically impossible to prepare multiplesets of devices for a patient. As the result, in many cases the patientis not receiving the device that is the best fit for their needs.

SUMMARY OF THE INVENTION

Disclosed herein are methods of manufacturing dental devices, the methodcomprising: obtaining a set of clinical options for the dental devicesfrom a health care provider in the form of a prescription hereinreferred to as the “Rx,” which includes the treatment plan for thepatient; creating a first data set from the set of clinical options;communicating the data set to a computer aided design (CAD) software;preparing a digital design for the dental devices using the CADsoftware; communicating the digital design to an automated millingapparatus; and automatedly milling a block of polymer to obtain thedental device. Also disclosed are dental devices manufactured by theabove method. Further disclosed are methods of treating or amelioratingsleep apnea or a jaw-related disorder in a patient, the methodcomprising obtaining a dental device manufactured by the above methodand positioning the dental device over the dentition prior to sleep,whereby the mandible is advanced forward, vertically, laterally or acombination of the three, relative to the maxilla, thereby amelioratingthe symptoms of sleep apnea or the jaw-related disorder.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a front view of an embodiment of the disclosedmandibular advancement device as it is worn in the mouth, whereas FIG.1B shows a side view of the same embodiment.

FIG. 2A illustrates an embodiment of the upper splint of the disclosedmandibular advancement devices where the rake angle is set in a neutralorientation, and FIG. 2B is an illustration of an embodiment of thelower splint.

FIG. 3A illustrates an embodiment of the disclosed mandibularadvancement device where the rake angle is set in a recline orientation.FIG. 3B illustrates an embodiment of the disclosed mandibularadvancement device where the rake angle is set in a proclineorientation.

FIG. 4A illustrates an embodiment of the fin design in a predesigneddigital library of fins. FIG. 4B illustrates another embodiment of thefin design in a predesigned digital library of fins. FIG. 4C illustratesanother embodiment of the fin design in a predesigned digital library offins. FIG. 4D illustrates another embodiment of the fin design in apredesigned digital library of fins. FIG. 4E illustrates that a findesign from the library is incorporated into an embodiment of thedisclosed mandibular advancement device.

FIG. 5 illustrates an embodiment of the disclosed mandibular advancementdevice where there exists a gap between the lower fin and the lowersplint.

FIG. 6 illustrates varying the plane of the splint with respect to theocclusal plane.

FIG. 7 shows the occlusal side of a splint with cutouts designed intothe device to accurately place ball clasps.

FIG. 8A shows a free standing upper splint with the retention arms,while FIG. 8B shows the graphics of how the upper splint and theretention arms fit into the mouth of the patient.

FIG. 9 shows the mechanism of titration when using multiple uppersplints with one lower splint. Each illustrated upper fin belongs to aseparate upper splint

DETAILED DESCRIPTION OF THE EMBODIMENTS

The present disclosure is directed to a method of obtaining informationabout a patient's dentition and the preferences of the patient and/or ahealth care provider in order to manufacture a set of dental appliancesthat match the patient's needs. Previously, embodiments of a particulardental appliance, namely a mandibular advancement device, have beendisclosed. See, for example, the International Publication WO2015/103084 (the entirety of this publication, including all thedrawings, is incorporated herein by reference, in particular thefollowing sections describing the device and the methodology oftitration: Paragraphs [0019]-[0053] and FIGS. 1A-4E and 7-9). Themethods and products disclosed herein are used in connection with thedevice described in the above-incorporated document, or any other devicethat is currently on the market, or other novel combinations of devicesand accessories.

In one embodiment the device creates an offset between the upper andlower splint by using upper and lower fins as boundary surfaces torestrict movement while the mouth is closed or reasonably opened.

In some embodiments, the devices disclosed herein were digitallydesigned and then milled as a single unit. In some of these embodiments,a computer aided design (CAD) process were used to design andmanufacture the mandibular advancement devices disclosed herein. Aplaster model of the patient's dental impression was first obtainedusing well-known techniques in the art. Then, scans of the plastermodels were imported into the CAD software. In other embodiments, the 3Dfiles of the patient's impression are imported from other sources, suchas a direct scan of the patient dentition using an Intra Oral Scan (IOS)Device, e.g., the 3M TruDef™ scanner, or a direct scan of the impressionfrom either an IOS or Cone Beam Computed Tomography (CBCT) device. Inthese embodiments, the files enable the design of the mandibularadvancement splint in 3D space in a CAD software such as 3-Matic byMaterialise™.

In other embodiments, the different components of the disclosed devices,for example the splint, the fins, the retention arms, etc., are milledor manufactured separately and then attached together after themanufacturing. This approach allows for the use of interchangeableparts.

In one embodiment the digitally designed and milled splints arereproduced accurately without manual polymer buildup. In someembodiments, accurate reproduction results in accurate replacementdevices. In other embodiments, it results in reproducible titrationsettings. In some embodiments the splints are digitally designed andmilled to provide access to pre-cured polymeric materials, and whereinthe device has minimal residual monomers.

In one embodiment one or more identifying information, e.g., thepatient's name, order number, and other relevant tracking information,are designed into the device. The identifying information appears on thedevice through the milling process.

In one embodiment, the device is designed to comfortably fit on to apatient's upper and lower arches, maintain a maximum amount of space forthe tongue, and keep the mandible advanced forward per a doctor'sprescription while still allowing the patient to reasonably open theirmouth and move their jaw from left to right for comfort. This contactserves as a barrier to keep the lower fin in a position forward of thisfin engagement surface.

The disclosed devices can be made from any material that can withstandthe oral environment for an extended period of time, for exampleovernight. Furthermore, the material can be any material that is capableof being milled to form the devices disclosed herein. Examples ofmaterials include plastics and other polymers, whether hard or soft,transparent or opaque. Some suitable polymers include, but are notlimited to, a polyetheretherketone (PEEK), polystyrene, polyvinylchloride, rubber, synthetic rubber, or an acrylate polymer, such as apolymer made up of methyl methacrylate, methyl acrylate, ethyl acrylate,2-chloroethyl vinyl ether, 2-ethylhexyl acrylate, hydroxyethylmethacrylate, butyl acrylate, butyl methacrylate, or trimethylolpropanetriacrylate (TMPTA).

Embodiments of the device are further described with reference to theaccompanying drawings.

FIG. 1 illustrates an embodiment of the disclosed mandibular advancementdevice, 100. FIG. 1a shows a front view of the device as it is worn inthe mouth, whereas FIG. 1b shows a side view of the same embodiment. Thedevice 100 comprises and upper splint 102 and a lower splint 104. Thesplint 102 is configured to fit snuggly onto the upper dentition 106,while the lower splint 104 is configured to fit snuggly onto the lowerdentition 108. Each splint provides enough retention to keep the deviceon during normal wear but allowing the user to pull off the device withminimal effort. The two splints contact each other along the occlusalplane 110, i.e., the plane passing through the biting surfaces of theteeth.

In one embodiment the thickness of the upper splint 102 and lower splint104 is independently varied to create a fixed amount of jaw openingbetween the patient's arches.

The devices 100 disclosed herein are prepared individually and speciallyfor a particular patient. For this reason, while preparing the digitaldesign of the disclosed devices, the idiosyncrasies of the patient'soral and dentition structures are taken into account. For instance, insome embodiments, the opposing surfaces of the splint are designed invariance with each other to accommodate the patient's oral structure toachieve maximum comfort. The surfaces can be flat or be made to touch atone or more points. This is true of any other feature of the devices100. For example, the height, width and shape of the fins; the rakeangle; the offset position of the fins; the location of retention arms,if any; the dental impressions; inter alia, are designed specificallyfor the particular patient. This feature is easily enabled with a devicethat is digitally pre-designed. The currently available devices arehandmade, making it difficult for the artisan to accurately take intoaccount the specific oral features of a particular patient.

Each upper splint 102 comprises at least one upper fin 114, andpreferably two upper fins 114. The fin 114 is located to the side of theupper splint 102 such that when the splint 102 is worn by the patient,the fin 114 is near the molars. Each upper fin 114 protrudes downwardly.

Similarly, each lower splint 104 comprises at least one lower fin 116,and preferably two lower fins 116. The fin 116 is located to the side ofthe lower splint 104 such that when the splint 104 is worn by thepatient, the fin 116 is near the molars. Each lower fin 116 protrudesupwardly.

Throughout the present disclosure, the terms “up,” “upper,” or “upward,”and “down,” “lower,” or “downward” refer to the relative position of theupper jaw and the lower jaw. Thus, “protruding downwardly” meansprotruding away from the upper jaw and towards the lower jaw. Similarly,the words “front” or “forward” and “back” or “backward” refer to therelative position of components in the mouth. Thus, “front” meanstowards the lips, whereas “back” means towards the throat, when thedevice is in the mouth.

FIG. 2A shows the embodiment of the upper splint that is shown in FIG. 1and FIG. 2B shows the embodiment of the lower splint that is shown inFIG. 1. FIG. 2 depicts the splints by themselves and without being wornon the teeth.

The upper fin 114 comprises a front surface 202 and the lower fin 116comprises a back surface 204. When the device is worn in the mouth, thelower fin 116 is located in front of the upper fin 114. The frontsurface 202 of the upper fin 114 contacts the back surface 204 of thelower fin 116. This contact serves as a barrier to keep the lower fin ina position forward of this fin engagement surface. That is, the contactprevents the lower jaw from moving backward relative to the upper jaw.Thus, once the device is worn, the relative forward position of theupper and lower jaws becomes fixed. The patient would be able to openand close their mouth and move the lower jaw from left to right forcomfort. However, the patient would not be able to move the lower jawbackwards beyond the point of contact of the two surfaces 202,204.

In one embodiment the device is digitally designed and milled to provideoptimal strength with reduced interference to the tongue creating acomfortable and durable device. As seen in FIGS. 2A & 2B, the twosplints each form an arch with an empty center 206. The empty center 206provides room for the patient's tongue when the device is in use. Thetype of design that allows room for the tongue is referred to aslingual-less. Thus, some embodiments of the present device 100 arelingual-less designs.

The upper fin 114 is located at a distance UD (208) from the back of theupper splint 102. Similarly, the lower fin 116 is located at a distanceLD (210) from the back of the lower splint 104. Distances 208,210 arealso referred to as fin offset. The relative positioning of the finsdetermines the degree to which the lower jaw is protruded forward, i.e.,the jaw offset. As discussed below, in some embodiments, the distances208 and 210 are manipulated to provide the best fit for the patient.

In one embodiment, the upper and lower fins vary in angular shape at thecontact surfaces of each fin to provide the most anatomically correctposition and comfort during the motion of opening and closing the mouth.The embodiment shown in FIG. 1 comprises vertical contact surfaces. Inthese embodiments, the contact surfaces 202 and 204 are perpendicular tothe occlusal plain 110. In this embodiment, the rake angle, i.e., theangle that surface 202 makes with the occlusal plane 110, is 90° to theocclusal plane, i.e., a neutral angle. In other embodiments, for examplethose shown in FIGS. 3A and 3B, the contact surfaces are at anon-neutral angle. For example, in the embodiment shown in FIG. 3A, therake angle is set in a recline orientation. In this embodiment, thesurface 202 angles backward. Conversely, in the embodiment shown in FIG.3B, the rake angle is set in a procline orientation. In this embodiment,the surface 202 angles forward. The rake angle is configured to drive adirectional movement during the opening and closing of the mouth. Theparticular angle, i.e., whether neutral, incline, or procline, and theangle degree, are chosen based on clinician prescription and patientcomfort.

In one embodiment, the fins are selected from a predesigned digitallibrary of fins. FIG. 4 shows additional embodiments of the fin design.FIGS. 4A-4D show some of the embodiments used in a fin library. In someembodiments, a designer calls from a library of fin designs, for examplethose shown in FIGS. 4A-4D, select one fin type (for example that shownin FIG. 4C), and place onto the custom patient splint design, as shownin FIG. 4E.

In some embodiments, for example that shown in FIG. 5, there exists agap 502 between the lower fin 116 and the lower splint 104. While thefin 116 is attached to the splint 104 at the base, the fin 116 protrudesslightly outwards before protruding upward. In some embodiments, acorresponding gap exists between the upper fin 114 and the upper splint102. The gap 502, if present, is designed into the device based on theprescription and patient anatomy and comfort. The gap 502 further allowsfor the side to side motion of the lower jaw with respect to the upperjaw.

When the device is worn by a patient and the patient's mouth is closed,the bottom surface of the upper splint and the top surface of the lowersplint contact each other along the curve of the device, i.e., the archof the mouth. The two surfaces contact each other along the plane of thesplint. In one embodiment the opposing surfaces of the splint aredesigned such that the plane of the splint equals the occlusal plane. Insome embodiments the plane of the splint is at an angle to the occlusalplane. FIG. 6 illustrates the ability to design devices in varyingdegrees of angle of the plane 110 of the splint to the occlusal plane602. In CAD, the angle of the plane 110 of the splint can be adjustedwithin the sagittal plane relative to the patient's anatomical occlusalplane 602. Moreover, the angle of the plane 110 can be adjusted withinthe frontal plane relative to the patient's occlusal plane 602.

Both adjustments are useful to the clinician to affect changes to therelative positioning of the mandible and maxillae. The path of themovement of the upper and lower arches, for the opening and closing ofthe mouth, is affected by the engagement surface 604, i.e., where thecontact surfaces 202 and 204 meet. If the engagement surface 604 is notproperly designed, then the upper and lower arches open and close alongan unnatural arc, causing pain for the patient. In manufacturing thedisclosed devices 100, the natural arc of the patient's jaw movement istaken into account in the digital design. The engagement surface 604 isthen designed to fit the natural arc.

In some embodiments, the device 100 is made of transparent materials,for example transparent plastic, to allow the clinician to see thepatient's dentition through the device 100 to ensure good fit. Thus, insome embodiments, the clinician can insert a generic device 100 into thepatient's mouth and mark the various measurements on the transparentdevice 100 instead of preparing a dental impression. In otherembodiments, a transparent device 100 is prepared first, and relativelyinexpensively, and the fit is tested before a more expensive andpermanent device is manufactured.

In some embodiments the fins vary in length. In certain embodiments, thefins are adjusted to the patient's open mouth dimensions. In someembodiments, the fins vary in length related to the opposing fin tooptimize the length required to maintain mandible offset position whileconsidering comfort such that each fin is the same length or a fractionof the length of the opposing fin. The sum of the heights of an upperfin 114 and lower fin 116 is the total range of contact along theengagement surface before the two splints are separated. At the point ofseparation, the two splints do not exert pressure on each other and donot provide any jaw offset. In some embodiments, the upper fin 114 andlower fin 116 are of equal heights. In these embodiments, the totalrange is optimized while minimizing the height of either fin. The ratioof the heights of each fin can also be adjusted for patient comfort orclinical reasons.

In some embodiments, the thickness of each fin can be adjusted to applymore or less pressure against the cheek. The pressure on the cheekstimulates the body to adjust the muscles in the mouth area, e.g., theairway muscles, for patient comfort or clinical reasons.

In one embodiment the device embeds one or more structural features thatcreate strength using less material. In some embodiments the structuralfeature is made from a single material. The term “embed” as used hereinrefers to a single material with design geometries or purposefullymilled slots or other geometries that enable another material to beadded as a support member, in the same way a rebar can strengthen aconcrete block. In some embodiments the structural feature is made froma combination of materials, such a metal alloy. In some embodiments themetal or metal alloy is in the shape of a ball clasp, retention wire, ortreatment wire. In some embodiments the treatment wires comprise ofwires to aid in a clinical result deemed important by the practicingdoctor, such as retention wires, alignment wires, or a tongue behaviormodification wire such as spikes or barbs to affect tongue thrust.

A patient inserts the disclosed devices 100 into the patient's mouthbefore sleep and removes them after sleep. The devices should beretained in the mouth snugly enough so that the device does not fall outwhile the patient is sleeping. However, the fit cannot be too snug sothat the patient cannot easily remove the device after waking up. Theretention of the device 100 in the mouth is achieved using a combinationof one or more of a variety of retention devices and gaps in spacebetween the device and tissue.

In one embodiment the device is retained onto the teeth of a patientusing patient specific retention arms. In some embodiments, theretention arms replace or improve the classic use of ball clasps. In theembodiments where ball clasps are used, space for their placement caneasily be designed into the splint. In one embodiment, FIG. 7 shows theocclusal side of a splint with cutouts 702 designed into the device toaccurately place ball clasps.

In some embodiments, for example that shown in FIG. 8, the device 100comprises retention arms 802, built into either or both of the uppersplint 102 and lower splint 104. The retention arms 802 allow for a moresecure placing of the splints into the mouth. FIG. 8A shows a freestanding upper splint 102 with the retention arms 802, while FIG. 8Bshows the graphics of how the upper splint 102 and the retention armsfit into the mouth of the patient. In some embodiments, the retentionarms 802 take on the shape of the classic ball clasp, while in otherembodiments, the retention arms 802 perfectly conform to the patient'sanatomy to optimize strength and surface area for retention whileallowing for maximum space for the tongue.

In some embodiments, a gap is designed between a particular devicesurface and one or more surfaces of a patient's anatomy. A purpose ofthe gaps is to allow the device 100 to be installed easily, stayretained under normal conditions, and be removed easily as well. In someembodiments, the gap is uniform across the entire contact region betweenthe device and the patient's tissue. In other embodiments, the gap isstrategically placed with properly designed spacing to provide easyinstallation of the device in the mouth, optimal device retention ontothe patient's dentition, or ease of use of the device. The gap is easilyprogramed into the CAD digital design. Because the disclosed device canbe prepared quickly and inexpensively, the clinician or the designer canexperiment with a series of different gap placings until the best fit isobtained.

It is possible, through a series of steps, called titration, to choosethe device having the most clinically relevant mandibular advancementsetting for the patient. Thus, in another aspect, disclosed hereinmethods of selecting a mandibular advancement device for a patient, themethod comprising:

a) obtaining two or more upper splints of the mandibular advancementdevice, wherein each upper splint comprises one or more upper fins,wherein each upper fin is located at a distance UD from back of theupper splint, and wherein the distance UD of any of the two or moreupper splints is different than the distance UD of any other of the twoor more upper splints; and

-   -   obtaining two or more lower splints of the mandibular        advancement device, wherein each lower splint comprises one or        more lower fins, wherein each lower fin is located at a distance        LD from back of the lower splint, and wherein the distance LD of        any of the two or more lower splints is different than the        distance LD of any other of the two or more lower splints;

b) choosing a combination of one upper splint and one lower splint forthe patient;

c) observing the clinical outcome of the chosen combination of one uppersplint and one lower splint;

d) choosing a different combination of one upper splint and one lowersplint for the patient if the clinical outcome of step c) isunacceptable; and

e) repeating steps b)-d) until an acceptable clinical outcome isobtained.

Once a digital scan of the patient's dentition is obtained, a number ofupper and lower splints are milled for the patient. Each of the upperand lower splints has a different fin offset setting. The clinicianchooses one set of upper and lower splints for the patient. If thepatient's condition is not improved sufficiently, the clinician thenchooses another set of splints. This process is continued until a set ofsplints providing the best clinical outcome is chosen. An advantage ofthe devices and methods disclosed herein is that by digitally designingthe splints and automatedly manufacturing them, several splints can beprepared relatively quickly and inexpensively. Further, the digitaldesign allows for a precise positioning of the fins. A more effectivemandibular advancement can then be obtained than by using a hand-milledand hand-cranked device.

In some embodiments, the titration settings provide for a flexiblepositioning of the fins in the mouth in the mesial-distal direction. Insome embodiments, the fit of the device 100 on a patient is titratedthrough the use of devices 100 with varying distances 208 and 210 (seeFIG. 2). In certain embodiments, the device 100 is milled directly froma CAD file such that the accuracy of the data from the impression of thepatient's anatomy, the fit of the device to that data, and the design ofthe device are precisely transferred to the milling machine. Thisenables very precise design adjustment in positioning each of the finsin the splint, i.e., the measurement of the distances 208 and 210, andin their position relative to each other in a reproducible andmanufacturable way.

For example, in one embodiment, three different upper splints 102 weremanufactured having increasingly longer distances 208, i.e., longer finoffset. Also, two different lower splints 104 were manufactured havingtwo different distances 210. Thus, pairing one lower splint 104 with oneupper splint 102 provided one jaw offset, while pairing the same uppersplint 102 with a different lower splint 104 provided another jawoffset, and so on.

An illustrative example is shown in Table 1. To compile this table, fivedifferent upper splints 102 were prepared having 0.0 mm, 1.0 mm, 2.0 mm,3.0 mm, and 4.0 mm fin offset (distance 208), respectively. Also, fourdifferent lower splints 104 were prepared having 0.0 mm, 0.5 mm, 1.0 mm,and 2.0 mm fin offset (distance 210), respectively. The combination ofthe two different splints can provide a jaw offset ranging from 0.0 mmto 6.0 mm, as shown in Table 1, where U-1 to U-5 are the upper splintoffsets (shown in parentheses) and L-A to L-D are the lower splintoffsets (shown in parentheses).

TABLE 1 U-1 U-2 U-3 U-4 U-5 (0.0 mm) (1.0 mm) (2.0 mm) (3.0 mm) (4.0 mm)L-A 0.0 mm 1.0 mm 2.0 mm 3.0 mm 4.0 mm (0.0 mm) L-B 0.5 mm 1.5 mm 2.5 mm3.5 mm 4.5 mm (0.5 mm) L-C 1.0 mm 2.0 mm 3.0 mm 4.0 mm 5.0 mm (1.0 mm)L-D 2.0 mm 3.0 mm 4.0 mm 5.0 mm 6.0 mm (2.0 mm)

Thus, twenty different mandibular advancements can be obtained with onlynine different splints, four lower splints and five upper splints.

Depending on the clinician's prescription need, the clinician choosesany reasonable value for the offset of the upper fin relative to thelower fin, and as many offsets as the clinician desires. Since thedigital manufacturing process accurately and precisely reproduces thesplints, the combination of splints is repeatable, regardless of whenthe clinician orders several splints or splints with other offsetdistances.

Another advantage of the disclosed splint combination is enabling thecreation of the same offset with different combinations of upper andlower splint positions. For example, as shown in Table 1, a 3.0 mmoffset may be created using three different combinations of upper andlower fins (L-A/U-4, L-C/U-3, and L-D/U-2). Varying the combinedposition of the two fins allow better alignment of the fins within themouth for reasons of patient comfort and clinical requirements.

FIG. 9 illustrates the titration. Three separate upper splints 102 areprovided, one having an upper fin offset of 1 mm (114-A), one having anupper fin offset of 2 mm (114-B), and one having an upper fin offset of3 mm (114-B) (FIG. 9 shows all three of these upper splints superimposedon each other for illustration purposes. In actuality, they are separatesplints.) One lower splint 104, having a lower fin offset of 0.5 mm(116) is also provided. Not shown is a lower splint 104 having a lowerfin offset of 0 mm. The following combinations of splints provide themandibular advancements of Table 2.

TABLE 2 Upper Lower 1.0 mm 2.0 mm 3.0 mm 0.0 mm 1.0 mm 2.0 mm 3.0 mm 0.5mm 1.5 mm 2.5 mm 3.5 mm

In another aspect, disclosed herein are methods of reducing partialconstriction of airway during sleep for a patient, the method comprisingidentifying a patient in need thereof; and administering to the patientthe mandibular advancement device as disclosed herein.

In another aspect, disclosed herein are methods of manufacturing amandibular advancement device, the method comprising obtainingmeasurements from a patient's dentition; digitally designing amandibular advancement device; and milling the mandibular advancementdevice. In some embodiments, the obtaining measurement step comprisesobtaining a dental impression.

While the methodology disclosed herein can be practiced through numerousdifferent, and varied, steps, the steps can be thought of as fallinginto at least three separate, yet connected, stages. First, a healthcare provider (HCP) examines the patient and obtains an impression ofthe patient's dentition, and models the bite by taking a bite impressionin one or more positions of the mandible relative to maxilla. Therelative position of the jaw bones also includes the position of thecondyle in the mandibular fossa. The impressions can be takentraditionally with dental impression material and poured up in stoneeither at the HCP office or at the manufacturing laboratory or site(MFG). Additionally, the HCP may digitally capture the patientdentition, bite (for example relative bite position) and anatomy andsend the resulting data set to the MFG. The HCP may also capture theposition of the mandible relative to the maxilla at several positionssuch that a range of motion can be modelled from which an ideal newposition for the mandible, which was not captured in the clinic, can becreated in the CAD software. In some embodiments, the HCP also capturesdata regarding the patient's anatomy. These data may include cone beamcomputer tomographic (CBCT) images of the temporomandibular joint (TMJ),facial landmarks, airway anatomy, and the like.

Then, based on the patient's needs and anatomy, the HCP selects severalclinical options, discussed fully below, for the particular device ofinterest for the patient. Second, the HCP communicates these clinicaloptions to the MFG. The MFG creates a computer aided design (CAD) of thedevice, having the selected clinical options. Third, the design iscommunicated to an automated manufacturing machine, which creates theselected device from a block of an appropriate material. Other machinescan then install other accessories that cannot be manufactured as asingle contiguous unit along with the device. The CAD process may createseveral devices from the same data set, each device designed to serve adifferent aspect of the treatment plan, such as nighttime treatment ofsleep apnea or bruxing, or daytime treatment for pain relief oraesthetics, where the device places the mandible in a different positionrelative to the maxilla for a specific outcome related to the treatmentplan.

In some embodiments, the block is made up of a solid material. Incertain embodiments, the block is a polymeric block. In otherembodiments, the block is made of a natural substance, for examplemetal, wood, natural resin, natural rubber, and the like. In otherembodiments, the block is made of synthetic polymeric material, havingeither one type of monomer or two or more co-polymers.

The automated fashion by which the dental devices are prepared allow fora multitude of different devices, having different features, to beprepared rapidly and economically, where the devices are identicallymanufactured. This allows for the patient and the HCP to experiment witha number of different option to see which one fits the patient's mouthand dentition better. This process cannot be effectively done using thecurrent technologies because the current dental devices are preparedartisanally by hand, which introduces variations into the manufactureddevices, even when they are prepared from the same exact set ofrequirements.

Thus, in one aspect, disclosed herein are methods of manufacturing adental device, the method comprising:

-   -   obtaining a set of clinical options from a HCP;    -   creating a first data set from the set of clinical options;    -   communicating the data set to a computer aided design (CAD)        software;    -   preparing a digital design for the dental device using the CAD        software;    -   communicating the digital design to an automated manufacturing        apparatus; and    -   automatedly manufacturing the dental device.

In some embodiments, the steps of preparing the digital design,communicating the design with the manufacturing apparatus, andmanufacturing the device, are repeated for each of the desired devices.In some of these embodiments, however, the same patient data set is usedto manufacture the multitudes of devices. In some embodiments, theseveral devices are used in sequence. For instance, if the mandibularrepositioning is meant to include repositioning in various directions,one device may be used to reposition the mandible from a first to asecond position, a second device is used to reposition the mandible fromthe second to a third position, and etc.

In some embodiments, the HCP is a dentist. In other embodiments, the HCPis a dental technician. In other embodiments, the HCP is a sleepdisorder specialist. In certain embodiments, the HCP is an individualcharged with altering the position of the patient's mandible (e.g., theuse of mandibular advancement devices). In other embodiments, the HCP isan individual charged with straightening a patient's teeth (orthodontia)(e.g., the use of braces and the like. In other embodiments, the HCP isa Temporal Mandibular Joint (TMJ) and Disease (TMD) specialist whorepositions the mandible to manage pain. In certain embodiments, thepatient is a human.

In some embodiments, the presently disclosed methods produce amandibular advancement device that is worn at night during sleep, whilein other embodiments, additional or singular devices are designed to beworn during the day. In still other embodiments, the device can be used24 hours a day.

Dentition Impression

Obtaining the data regarding the shape of the patient's dentition iswell-known to those of ordinary skill in the art. In some embodiments,the HCP obtains the dentition impression using trays filled withimpression materials. The impression is then used to create a plastermodel identical to the patient's dentition.

In some embodiments, the HCP provides photographs of the patient'sdentition. A computerized three-dimensional (3D) image of the patient'sdentition can then be prepared. In some embodiments, the patient'sdentition is scanned, for example with an intraoral scanner, while inother embodiments, the plaster model of the patient's dentition isscanned. The scanning data is used to create a computerized 3D image ofthe patient's dentition.

A clinically obtained data set can be obtained from the patient'sanatomy using techniques such as, but not limited to, X-ray imaging,dental impressions, intraoral scanning, cone bean computed tomography(CBCT), palpitations of the area around the jaws, visual inspection ofthe dentition, or patient testimony. The term “anatomy” includes anypatient data that refers to hard or soft tissue, or specific featuresthat describe that tissue, that may include well known landmarks such asmolar cusps, height of contour, anatomical planes, facial landmarks ordescriptive values such as arch shape, tongue size, or Malampatti scoreand the relationship between the hard and soft tissue to appearance orfunction. The data set is then used to create a patient specificprescription that is precisely implemented into the treatment device viaa CAD/CAM platform and/or a matrix-generated prescription of variousoption, such as the one disclosed in U.S. patent application Ser. No.15/416,715, the entire disclosure of which, including any drawings, isincorporate by reference herein.

In some embodiments, patient testimony includes descriptions of symptomsrelated to sleep breathing disorders, such as sleep apnea, snoring,upper airway resistance syndrome (UARS) or symptoms related tomalpositioning of the mandible affecting the patency of the airway ordiscomfort at the temporal mandibular joint (TMJ) realized as temporalmandibular disorder (TMD). The mandible is capable of being positionedin the anterior-posterior direction (AP), being positioned in thevertical dimension (perpendicular to the occlusal plane), or rotatearound an axis contained in the occlusal plane. Sometimes the comparisonto an airplane or a ship having the three axes of rotation of pitch,yaw, and roll is a useful analogy.

In some embodiments, an HCP provides instructions based on the currentposition of the patient's mandible and a desired treatment position. Thedesired treatment position can be determined by many methods, includingpositioning the mandible in an open and protruded position using aGeorge Gauge, ProGauge, Airway Metrics or other like gauges.Additionally, there are methods that use enunciation of numbers such as“sixty six” to provide a guide for a treatment position. The HCP canalso use airway analysis using CBCT software in the two positions(current and desired), evaluate the alignment of the condyle in thefossa for TMJ positioning or use X-ray imaging for anatomicalmeasurements. For example, the position of the condyles for the left andright side of the patient could be measured relative to an establishedhealthy position. In other embodiments, the HCP may also find an optimalposition for the mandible using heart rate variability, or othersystemic body variables. The difference in the left and right positionsrelative to the treatment position can then be documented and writteninto the prescription creating the proper protrusion (symmetrical orasymmetrical), vertical repositioning, and any other angular componentsof the mandibular position. The positioning of the mandible may alsomeet patient needs concerning the aesthetics of the face and the impactof a new mandibular position to the look of the face.

Selecting Clinical Options

The set of clinical options is prepared based on the HCP' sdetermination of what is required and/or most effective for thetreatment of the patient. Thus, the set of clinical options is at timesreferred to as the “prescription” or “Rx” that the HCP provides for thetreatment of the patient.

Throughout the present disclosure, the word “option” or the phrase“clinical option” as it relates to the selectable options for a dentaldevice, refers to a category of features. For example, titration optionrefers to the category of available titration features. Titrationoptions serve to create the method of advancement of the mandiblerelative to the maxilla. Each particular feature under an option is a“selection.” Thus, the HCP chooses a selection under an option.

After examining the patient's dentition and oral anatomy, the HCPobtains information regarding the shape of the patient's dentition orthe range of motion of the patient's jaw. The range of motion includes,but is not limited to, rotational and translational movements of themandible, such as protrusive movement, vertical movement, lip competency(i.e., the extent a person can separate their jaws while keeping thelips closed), or golden proportions (i.e., the aesthetically acceptedratios of teeth size to facial dimensions and symmetry). Commonly, thisis done by generating an imprint of the dentition on a polymer or dentalimpression material. In other embodiments, the data regarding the shapethe dentition is obtained by analyzing photographs of the dentition, orby a machine reading the contours of the dentition.

Next, the HCP selects a series of clinical options for the dentaldevice. These clinical options relate to the material that makes up thedental device, the mechanism of titration, and other physical featuresof the device. These clinical options are described in detail below.

In some embodiments, the selection of the clinical options is through aweb portal. In these embodiments, a website is provided for the HCP tocommunicate the clinical options with the MFG. In some embodiments, thewebsite provides a questionnaire where the HCP provides a writtenresponse to questions relating to each option. In other embodiments, theclinical options are listed with a radio button next to each. The HCPchooses the desired option by clicking on the appropriate radio button.In yet other embodiments, the HCP selects the desired option from adrop-down window, listing all the available selections for thatparticular option.

In some embodiments, the selection of options is intelligentlyorganized. By “intelligent organization” it is meant that when the HCPmakes an initial selection, then only groups of subsequent options thatcreate a viable device within the initial selection are enabled. Forexample, selecting elements of contradictory, weak or unsafe designs arenot allowed. The final grouping of the selections along with the patientinformation and HCP' s approval culminate in the prescription. Incertain embodiments, the intelligent organization of the selectionoptions include the availability of only those options for a particularselection that comply with regulatory requirements.

In some embodiments, the set of clinical options comprise two or moreclinical options selected from the group consisting of titrationmechanisms, titration accessories, splint design, retention mechanisms,splint material, and fin or strap design or sleeve (e.g., a covering fora fin). In certain embodiments, the clinical options include otherfeatures not enumerated herein.

“Titration” is the process of adjusting the relationship between themandible and the maxilla for a desire outcome (also referred to as“calibration”), such as relief of symptoms due to obstructive sleepapnea (OSA). Currently, examples of the titration techniques include thethreaded screw system on a device, where the patient or the HCP adjustor turn a small screw, which causes a portion of the dental device tomove to a position dictated by the HCP (U.S. Pat. No. 6,604,527); orchanging of straps of different lengths (U.S. Pat. No. 5,365,945). Anovel method of titration is disclosed in the above-incorporatedInternational Publication WO 2015/103084. Portions of the disclosure ofthe publications listed in this paragraph related to the adjustmentmechanism are incorporated by reference herein.

“Retention” is the process of fitting a device to the dentition, suchthat the device has a tight enough fit to be efficacious, yet has aloose enough fit to be comfortably worn by the patient. Retention mayalso be optimized to minimize the amount of tooth movement or bitechanges caused by wearing a device the imparts forces on the teeth andrelative position of the mandible and maxilla to each other.

“Titration mechanism” is a component or property of the device, thatthrough adjustment, the upper and lower arch splint relative positioncan be affected to achieve a patient outcome. For each mechanism, anumber of “titration accessories” is available, by way of which thetitration is carried out. These accessories are projections or additionsattached to a basic splint. In some embodiments, the titration accessoryis selected from the group consisting of an electronic ormicroelectronic device, a “smart” accessory (i.e., an electronic devicethat obtains data and communicates the data with another electronicdevice), affixed sleeve, removable sleeve, straps, anterior hinge, shortor long Herbst hinge, jack screw, and Herbst hinge in combination withjack screw, or any other appliance accessory now known or designed inthe future. In some embodiments, the accessory is separatelymanufactured from that of the base dental device. In these embodiments,the accessory itself is attached to the device after the manufacturingof the device. In other embodiments, the accessory is part of theunitary design of the device. In these embodiments, the accessory comesto being at the same time the device is manufactured. For example, afin, a strap, a hinge, a screw, etc., and combinations thereof, aretitration accessories.

In some embodiments, the titration mechanism is selected from the groupconsisting of microtitration series, jack screw titration, Herbst hingetitration, anterior hinge titration, strap titration, mechanical hook,and combinations thereof.

“Microtitration series” refers to the titration procedure disclosed inthe above-incorporated International Publication WO 2015/103084,particularly in Paragraphs [0051]-[0061], which paragraphs areexplicitly incorporated by reference herein. Through the use of themicrotitration mechanism, a number of upper and lower splints havingfins are manufactured for the patient. Each of the upper and lowersplints has a different fin offset setting. The clinician chooses oneset of upper and lower splints for the patient. If the patient'scondition is not improved sufficiently, the clinician then choosesanother set of splints. This process is continued until a set of splintsproviding the best clinical outcome is chosen. In one embodiment, theHCP may start with one titration mechanism and then switch one or bothsplints to incorporate another mechanism. For example, the upper archcould start with the “Jack Screw” and then be traded out for themicrotitration upper splint, which has a lower profile and is morecomfortable.

“Jack screw” (also known as “expansion screw”) titration refers to asystem of titration where the movable parts of the dental device areconnected by a screw. A nut is provided, whereby the turning of the nutcauses the movable parts to move with respect to each other so that theparts either come closer together or are moved further apart. An exampleof a jack screw titration is shown in FIGS. 15a and 15b of U.S. Pat. No.6,604,527 and the corresponding discussion in the specification thereof(incorporated by reference herein).

“Herbst hinge titration” is well-known to the skilled artisan. The hingecomprises a smaller cylinder that fits within a larger cylinder. Theuser can determine the extent to which the smaller cylinder can extendout of the larger cylinder, thereby limiting the extent of separation ofthe two cylinders. When one cylinder is attached to, for example, anupper splint of an advancement device and the other cylinder is attachedto the lower splint, then the two pieces can be separated by aprescribed distance. By lowering the distance, the user can titrate thedevice. A discussion of the Herbst device is found, for example, inVela-Hernandez et al., J Clin Orthod. 2004 November; 38(11):590-9(“Clinical management of the Herbst Occlusal Hinge appliance”). A Herbsthinge titration may also include a set of fixed bars that are swappedout for different protrusion levels.

In some embodiments, the titration mechanism is a hybrid mechanism. Inthese embodiments, two or more of the above mechanism, or in combinationwith other mechanism used in the art, are combined. An example of ahybrid titration mechanism would be the combination of microtitrationseries with expansion screw. An example of this type of a combinationdevice is disclosed in the International Publication No. WO 2017/132638(with a specification substantially equivalent to that of U.S.Provisional Application Ser. No. 62/533,420, incorporated by referenceherein in its entirety, including the drawings. For instance, the finlocation of one of the splints, e.g., upper or lower, is changed byreplacing the splint, as in the microtitration series, while the finlocation of the other of the splints is changed by the use of a screw.

In some embodiments, once the HCP has determined the titrationmethodology, the HCP can then pick the desired titration accessory toaffect the chosen methodology. In some embodiments, the titrationaccessory is selected from the group consisting of affixed sleeve,removable sleeve, straps, anterior hinge, short or long Herbst hinge,jack screw, Herbst hinge in combination with jack screw, andcombinations thereof.

An “affixed sleeve” is a protrusion immovably attached to the dentaldevice. The location of the protrusion on the splint, and morespecifically the relative positions of the sleeves on the upper andlower splints of the dental device, are fixed. An example of the affixedsleeve embodiment is found, for example, in FIGS. 7 and 6 of U.S. Pat.No. 6,604,527 and the corresponding discussion in the specificationthereof (incorporated by reference herein).

A “removable sleeve” is a covering that fits over an affixed fin on asplint of a dental device, thereby changing the thickness of the fin.Consequently, the relative positions of the upper and lower fins arechanged and the two splints of the device are located at a differentdistance from each other than without the sleeve. A number of sleeveshaving different thicknesses can be prepared for each fin. An embodimentof the removable sleeve is disclosed in the International PublicationNo. WO 2017/132638 (with a specification substantially equivalent tothat of the U.S. Provisional Application Ser. No. 62/289,131,incorporated by reference herein, particularly Paragraphs [0015]-[0040]and the drawings.

In one aspect provided herein is a digitally designed and milledmandibular advancement device comprising an upper splint and a lowersplint, wherein the upper and lower splints independently furthercomprise one or more fins. Also disclosed, to be used with the device,are a plurality of sleeves, each pair of sleeves having a uniquethickness and/or rake angle, and where the sleeves fit over the fins.

Thus, disclosed herein are sleeves for use with a fin of a mandibularadvancement device, the sleeve comprising:

-   -   a shell, having a wall defining a hollow interior,    -   wherein the wall encloses the hollow interior on all sides        except one, leaving an opening at one end of the body;    -   the wall has a thickness in the range of from about 1 nm to        about 5 mm;    -   the hollow interior comprises approximately the same size and        dimensions as the fin of the mandibular advancement device.

In some embodiments, the sleeved fins on the splints provide accurateincrements of advancement of the lower jaw for titration of themandible. The terms “dental splint” and “splint” as used herein refersto several types of orthodontic devices that are designed to addressdental problems such as loose teeth and bruxism, in addition to problemswith snoring and apnea. More specifically, the term “splint” refers toan upper or lower splint, having sleeveless fins, which splint isuniquely designed to fit over a patient's dentition. Thus, as isdisclosed further below, the present disclosure distinguishes between a“sleeveless-fin splint,” which is a splint that fits over the patient'sdentition but the upper and lower fins do not make sufficient contact toprovide the desirable extent of mandibular advancement, and “sleeved-finsplint,” where presently disclosed sleeves have been placed over theupper and lower fins of the splints, where the increased thicknessafforded by the sleeves causes mandibular advancement when the splintsare worn by the patient.

A patient in need of the disclosed mandibular advancement devices wearsthe upper splint on the upper dentition and the lower splint on thelower dentition during sleep. The splints are designed to remainattached to the dentition until the patient removes them. The sleevedfins of the upper and lower splints cause a precise placement of themandible in relation to the maxilla. The mandible is caused to stay in aforward position and does not relax and fall back. The airwayconstriction during the sleep is thereby minimized.

In one embodiment the device creates an offset between the upper andlower splints by using upper and lower sleeved fins as boundary surfacesto restrict movement while the mouth is closed or reasonably opened,e.g., opened to the same extent that the mouth opens during sleep.

In some embodiments, the splints with sleeveless fins, disclosed hereinwere digitally designed and then milled as a single unit. In some ofthese embodiments, a computer aided design (CAD) process were used todesign and manufacture the mandibular advancement devices disclosedherein. Plaster models of the patient's upper and lower dentalimpressions were first obtained using well-known techniques in the art.Then, scans of the plaster models were imported into the CAD software.In other embodiments, the 3D files of the patient's impression areimported from other sources, such as a direct scan of the patientdentition using an Intra Oral Scan (IOS) Device, e.g., the 3M TruDef™scanner, or a direct scan of the impression from either an IOS or ConeBeam Computed Tomography (CBCT) device. In these embodiments, the filesenable the design of the mandibular advancement splint in 3D space in aCAD software such as 3-Matic by Materialise™.

In other embodiments, the different components of the disclosed devices,for example the splint, the fins, the fin sleeves, the retention arms,etc., are milled or manufactured separately and then attached togetherafter the manufacturing. This approach allows for the use ofinterchangeable parts. The design and manufacturing processes aredescribed in the co-pending U.S. application Ser. No. 15/416,715, theentire disclosure of which, including the drawings, and especiallyParagraphs [0012]-[0053], inclusive, are hereby incorporated byreference.

In some embodiments, a unique single set of upper and lower splints withsleeveless fins are prepared for each patient. The patient is thenprovided with a library of sleeves that fit over the fins. By changingthe sleeves, the patient or the healthcare provider can change theextent of mandibular advancement. This approach to the manufacture anduse of mandibular advancement devices provides for a less costly, easierto use, and easier to manufacture approach to mandibular advancement.

In one embodiment, the splint is designed to comfortably fit on to apatient's upper and lower arches, and maintain a maximum amount of spacefor the tongue. The sleeved fin keeps the mandible advanced forward pera doctor's prescription while still allowing the patient to reasonablyopen their mouth and move their jaw from left to right for comfort. Thiscontact serves as a barrier to keep the lower sleeved fin in a positionforward of this fin engagement surface.

The disclosed devices can be made from any material that can withstandthe oral environment for an extended period of time, for exampleovernight. Furthermore, the material can be any material that is capableof being milled to form the devices disclosed herein. Examples ofmaterials include plastics and other polymers, whether hard or soft,transparent or opaque. Some suitable polymers include, but are notlimited to, a polyetheretherketone (PEEK), polystyrene, polyvinylchloride, rubber, synthetic rubber, or an acrylate polymer, such as apolymer made up of methyl methacrylate, methyl acrylate, ethyl acrylate,2-chloroethyl vinyl ether, 2-ethylhexyl acrylate, hydroxyethylmethacrylate, butyl acrylate, butyl methacrylate, or trimethylolpropanetriacrylate (TMPTA).

In some embodiments, a lower splint is provided with sleeveless fins. Insome embodiments, both the upper and lower splints comprise sleevelessfins configured to receive a sleeve. In other embodiments, one of theupper or lower splint comprises sleeveless fins configured to receive asleeve, while the other of the upper or lower splint is configured tomake contact with the sleeved fin of the other splint. That is, the finthickness and/or rake angle of one splint can be varied while the finthickness and/or rake angle of the other splint is kept constant. Whilethe disclosure here is in the context of the fins on a lower splint, theskilled artisan recognizes that both the upper and the lower splints, oreither of the upper or lower splints, can be made to exhibit the use ofthe sleeves disclosed herein.

In an embodiment of the lower splint, the right fin is a sleeveless finthat is configured to receive a fin. The left fin is a sleeved fin,where a sleeve has been placed over the fin. The sleeve increases thethickness of the fin and can provide a rake angle that is different thanthat of the fin, or that of other sleeves. In some embodiments, the rakeangle is 90°, while in other embodiments, the rake angle is betweenabout 20° to about 80°, for example, an angle selected from the groupconsisting of about 20°, about 25°, about 30°, about 35°, about 40°,about 45°, about 50°, about 55°, about 60°, about 65°, about 70°, about75°, and about 80°. In other embodiments, the rake angle is betweenabout 100° to about 160°, for example, an angle selected from the groupconsisting of about 100°, about 105°, about 110°, about 115°, about120°, about 125°, about 130°, about 135°, about 140°, about 145°, about150°, about 155°, and about 160°.

By “about” a certain value it is meant that the stated value comprisesthe range of values within ±25%, ±20%, ±10%, or ±5% of the stated value.Thus, by way of example only, if a distance is given as “about 5 mm,”the range of distances between 3.75 mm (5-25%) to 6.25 mm (5+25%) isenvisioned.

In some embodiments, each sleeve comprises an outer shell, which definesa hollow interior. Thus, the sleeve has an open end, where the hollowinterior is accessed, and a closed end opposite the open end. Thedimensions of the hollow interior are such that the sleeveless fin fitsinside the hollow interior. When worn over the fin, the open end of thesleeve abuts the splint, whereas the closed end is distal to the splint.

In some embodiments, the fit between the sleeve and the fin is such thatwhen the sleeve is placed over the fin, the sleeve is substantiallyimmobile with respect to the fin. By “substantially immobile” it ismeant that the movement of the sleeve with respect to the fin is notperceptible by the naked eye (that is to say, the sleeve does not“rattle” when it is placed over the fin).

In some embodiments, the closed end of the sleeve is curved away fromthe plane normal to the plane defined by the rim of the open end. Incertain embodiments, the curvature of the sleeve approximates thecurvature of the patient's mouth, whereas in other embodiments, thecurvature approximates that found in the mouth of an average patient.The curvature prevents the closed end of the sleeve to bore into, orunduly rub against the inside of the patient's cheeks and allows forgreater comfort for the patient when the device is worn.

The sleeve, and the corresponding sleeve for the upper sleeve, can eachhave one of a multitude of designs and shapes. In one embodiment, thesleeves are selected from a predesigned digital library of sleeves. Insome embodiments, a designer calls from a library of sleeve designs andselects one sleeve type. The design is selected based on the patient'sneed and the geometry of the patient's dentition and mouth. A set ofsleeves are then prepared having the desired sleeve design. The sleeveis then placed on the fin of the customized patient splint design.

The outer shell of the sleeve has a thickness. In some embodiments, thethickness is uniform throughout the perimeter of sleeve. In otherembodiments, the thickness varies from location to location in order toenhance the strength of the sleeve. In certain embodiments, at least thethickness along the contact surface of sleeve with sleeve varies fromone sleeve to another in a set of multiple sleeves prepared for the samepatient. Thus, by varying the thickness of either or both of sleeves,the extent of mandibular advancement is varied.

In some embodiments, the thickness can be varied, either within a sleeveor from one sleeve to another, for example, from a 1 nm to 5 mm, or from1 μm to 5 mm, or from 1 mm to 5 mm. In some embodiments, the thicknessis no more than 4 mm, 3 mm, 2 mm, or 1 mm.

Various locking mechanisms are contemplated to secure the sleeve overthe fin. In some embodiments, the sleeve is held in place over the finby a friction lock mechanism. In these embodiments, the tight fit of thesleeve over the fin creates enough friction that the normal use of thedevice does not dislodge the sleeve from over the fin. In some of theseembodiments, corresponding grooves (not shown) on one or both of thesleeve and fin increases the friction between the two pieces.

In other embodiments, the locking mechanism is a key-tab mechanism. Thetab mechanism is incorporated into the design of the sleeve. The tabmechanism is separated from the sleeve shell by a gap. The thickness ofthe gap can be varied, for example, from a 1 nm to 5 mm, or from 1 μm to5 mm, or from 1 mm to 5 mm. The tab has a length, which is less than thefull length of the sleeve. The length can be varied depending on thethickness of the shell, or the hardness of the material making up thesleeve, and in some instances depending on the dexterity of the patient,to provide for a convenient release operation, as discussed below.

At one end of the tab, either the end close to the open end or the endclose to the closed end of the sleeve, the tab is connected to thesleeve shell by a living hinge. In some embodiments, the living hinge isproximal to the open end of the sleeve. In some embodiments, the tabcomprises a key at the opposite end of the tab from the living hinge.Along the length, and between the living hinge and the key, a fulcrum islocated. The position of the fulcrum can be varied to provide the mostconvenient release operation for the patient.

In some embodiments, the fin comprises a notch. When the sleeve isplaced over the fin, the key fits into the notch, thereby holding thesleeve in place. To release the sleeve, the user pushes on the tab at alocation between the fulcrum and the living hinge. When the tab ispressed, the key moves in the opposite direction and the key is releasedfrom the notch, allowing the sleeve to be removed.

In some embodiments, the tab is located on the lingual side of thesleeve (i.e., the side facing the mouth cavity, or the tongue), whereasin other embodiments, the tab is located on the buccal side of thesleeve (i.e., the side facing the inside of the patient's cheek). Insome embodiments, the sleeve comprises at least two tabs, one on thelingual side and one on the buccal side. In other embodiments, the tab(or tabs, if there are more than one tab) are located on the surfacesorthogonal to the lingual and buccal surfaces. In certain embodiments,the tab is located on the surface opposite the contact surface. Thepresence of more than one tab provides additional locking strength.

In another embodiment of a locking mechanism, the fin on the splintcomprises a key button, such as a raised boss. The sleeve comprises akey threshold, which culminates in a key hole. The shape of the key holematches the approximate contours and size of the key button. In theseembodiments, the shape of the key button and the key hole isapproximately circular. The key threshold opens at the open end of thesleeve. The threshold provides a friction lock for the key button suchthat once the sleeve is placed over the fin and the key button is placedinside the key hole, the sleeve does not fall out of place without theuser intentionally removing the sleeve.

As discussed above, in the '208 application, the rake angle can bemodified to be in either neutral, procline, or recline orientation. Insome embodiments, the fin is in a neutral orientation and the rake angleis changed by changing the sleeve. In these embodiments, only the sleeveaffords a change in the rake angle. In other embodiments, both the finand the sleeve are oriented in the desired rake angle orientation.

In one aspect, provided herein are nesting sleeves. In some embodiments,different sleeves have different sized hollow interior, such as onesleeve can fit over another sleeve. To titrate the patient, first thesmallest of the selected sleeves (a “first sleeve”) is put over the finand the device is tested. if there is a desire to increase the extent ofmandibular advancement, then another sleeve, with a larger hollowinterior (a “second sleeve”), is placed over the first sleeve, therebyincreasing the overall thickness covering the fin. The next sleeve inthe set (a “third sleeve”) can fit over the second sleeve and increasethe thickness yet again.

In some of these embodiments, the thickness of the different sleeves isthe same, whereas in other embodiments, the thickness of one sleeve isdifferent than the thickness of another sleeve. In certain embodiments,the thickness of the second and subsequent sleeves on the buccal andlingual sides is kept relatively thin, i.e., 75%, 50%, 40%, 25%, or 10%,of the thickness of the sleeve on the contact surface side. By varyingthe thickness in this manner, the sleeve bulk in the patient's mouth iskept to a minimum while the mandibular advancement is increased.

In some embodiments, the sleeves having different thickness or differentsized hollow interior, have different colors. In certain embodiments,the sleeves are opaque whereas in other embodiments, the sleeves aretransparent. In some embodiments where the second sleeve fits over thefirst sleeve, as discussed above, the sleeves are both transparent andhave different colors. In certain of these embodiments, the colors ofthe first and second sleeves combine to form a new color. For example,and without limitation, in one embodiment the first sleeve is blue andthe second sleeve is red. When the second sleeve is placed over thefirst sleeve, then the combined color will be purple. In theseembodiments, the patient or the healthcare provider can quicklydetermine the extent of mandibular advancement by looking at the colorof the sleeved fin.

A “strap” is a rubber or stretchable plastic band that connects theupper and lower splints of a mandibular advancement device, therebyproviding mandibular advancement while allowing for a limited motion ofthe mandible. In some embodiments, the strap is elastic while in otherembodiments, the strap is not elastic. In some embodiments, the strap isstretchable while in other embodiments, the strap is not stretchable. Anexample of a device using straps is the EMA® (Elastic MandibularAdvancement) oral appliance (Glidewell Laboratories, Newport Beach,Calif.). In some embodiments, the strap is a non-stretchable strap, forexample as used with NARVAL™ CC (ResMed, San Diego, Calif.). In someembodiments, the strap is a link, which is a rigid, non-stretchable,strap, typically made from a rigid polymer or metal.

In some embodiments, the upper and lower splints of a dental device areconnected by a frontal, or anterior, hinge. The relative openness of thehinge determines the extent of the device's opening. An example of adevice using the anterior hinge is the TAP® (Thornton AdjustablePositioner) series of devices (Keller Lab, Fenton, Mo.).

While in some embodiments, the HCP chooses the titration methodologyfirst and then chooses the titration accessory, in other embodiments,the HCP chooses the titration accessory first, and then based on theaccessory chooses the titration methodology.

In some embodiments, the splint design is selected from the groupconsisting of a fin, anterior opening, anterior discluder, scallopedocclusal surface, lingual opening, a tapered posterior, a tongueattractor, lingualess, full lingual coverage, edentulous, posteriorlingual, anterior lingual, anterior lingualess, and monoblock.

The devices worn by a patient comprise a dentition arc that fits overthe patient's dentition. In some devices, the internal space of the arcis empty. In other words, in these devices the splint forms the shape ofa “U.” These devices are termed “lingualess” devices. (See, for example,SomnoDent® (SomnoMed®, Frisco, Tex.) and MicrO₂® (ProSomnus®,Pleasanton, Calif.)). In other devices, the posterior portion of thesplint, i.e., the ends of the “U” that cover the molars, are connectedtogether to provide additional strength to the device. The anteriorspace remains empty. These devices are termed “anterior lingualess”devices. In some other devices, termed the “full lingual coverage”design, the splint lacks the empty middle section.

A “posterior lingual” or “partially lingual” design is defined as thedesign of a dental device that covers the posterior teeth and provideslingual coverage adjacent to the posterior teeth. In this design, thedevice does not cover the lingual or possibly the labial sides of thefront teeth, e.g., the incisors. In some embodiments, the posteriorlingual design has an anterior portion that fits behind the front teeth.In other embodiments, the design has no anterior component. Theposterior lingual design exerts a different level of retention thanother designs, which may be of greater comfort for some patients. Thisdesign also enables a structured contoured design, and/or increases thestrength of the device while leaving the space behind the anterior teethminimally covered or not covered at all.

An “anterior lingual” design is defined as the design of a dental devicethat provides lingual coverage adjacent to the anterior teeth. Theanterior lingual design exerts a different level of retention than otherdesigns, which may be of greater comfort for some patients. This designalso enables a structured contoured design, and/or increases thestrength of the device

“Edentulous” designs are used when the patient lacks a complete set ofteeth. In an edentulous, or full edentulous, design, the patient has noteeth, and the device is designed for over the edentulous ridge, or forover the dentures. In a partially edentulous design, the device isdesigned to fit in the adventitious space between the teeth.Additionally, a fully edentuluous design can incorporate dental implantscrews with buttons that snap into the device for retention.

In a “monoblock” design, the upper and lower splints are fused togetherin one piece. A series of monoblock splints can create protrusionincrements similar to microtitration but with fused components.

In some embodiments, the retention mechanism is selected from the groupconsisting of implant-retained mechanisms, metallic ball clasps, plasticball clasps, dental buttons, soft liner, and a hard acrylic polymer.

Several different materials can be used to make splints using themethods disclosed herein. In general, the splint material has one ormore of the following attributes: the material has sufficient strengthto move the mandible; the material's malleability and/or compressibilityis less than 25% of the desired adjustment distance; the material doesnot disintegrate in the aqueous environment of the mouth; the materialdoes not leave a repugnant taste in the user's mouth; the material isbiocompatible with the patient's physiology; the material is strongenough to withstand the pressure exerted by the jaw bones during use;the material can be additively printed or manufactured and the materialcan be machine grinded into the desired shape. Some embodiments ofmethods of manufacturing are disclosed in U.S. application Ser. No.15/416,715, the entire disclosure of which, including the drawings, andspecifically Paragraphs [009]-[0059] of the specification as originallyfiled, are incorporated by reference herein.

In some embodiments, the splint material option is selected from thegroup consisting of standard polymethylmethacrylate (PMMA), lined PMMA,high-strength polyetheretherketone (PEEK), polymer produced frompolyoxymethylene and acetal copolymers (Duracetal®), glycol modifiedpolyethylene terephthalate (PETg), and a physiologically compatible,water insoluble, and non-maleable polymer. Other polymers meeting one ormore of the general requirements also be used. In certain embodiments,the splint is made of metal or wood.

When a splint having fins is used, the anterior surface of an upper fin,i.e., the mesial surface of a fin on the splint for the upper jaw,contacts the posterior surface of a lower fin, i.e., the distal surfaceof a fin on the splint for the lower jaw. In some embodiments, thesurfaces make an angle of about 90° with the patient's occlusal plane,while in other embodiments, the angle is obtuse, and in still otherembodiments, the angle is acute. In some embodiments, the angle is 90°,while in other embodiments, the angle is between about 20° to about 80°,for example, an angle selected from the group consisting of about 20°,about 25°, about 30°, about 35°, about 40°, about 45°, about 50°, about55°, about 60°, about 65°, about 70°, about 75°, and about 80°. In otherembodiments, the angle is between about 100° to about 160°, for example,an angle selected from the group consisting of about 100°, about 105°,about 110°, about 115°, about 120°, about 125°, about 130°, about 135°,about 140°, about 145°, about 150°, about 155°, and about 160°.

Each one of these designs has a set of unique advantages that the HCPmight find beneficial for the patient. The skilled artisan is familiarwith the advantages. Thus, in some embodiments, the fin or strap designoption is selected from the group consisting of, a normal fin, an acutefin, an obtuse fin, and straps in compression or traction setting.

In some embodiments, the set of clinical options further comprise anoption selected from the group consisting of an open anterior, ananterior discluder, a scalloped occlusal surface, a lingual opening, acompliance chip, an AM positioner, a tapered posterior, a tongueattractor, a bruxism package, lingualess, full lingual coverage,edentulous, posterior lingual, anterior lingual, anterior lingualess,and monoblock.

In some embodiments, the HCP chooses a device having an open anterior.These embodiments, typically direct the HCP to shy away from choosing ananterior hinge. Anterior discluders, such as the Best-Bite™ discluder(Whip Mix, Louisville, Ky.), are well known in the art. If the HCPchooses to incorporate an anterior discluder, it can be modeled into thesplint design and manufactured as a monoblock along with the splint.

In a device with “scalloped occlusal surface” the occlusal surface ofthe splint, for example the molar area, is contoured to match theocclusal surface of the dentition.

Devices with a “lingual opening” or “anterior opening” are devices thathave an opening in the anterior portion of the device that allows forair to move in and out of the mouth even when the mouth is partiallyclosed.

Some insurance companies require patient's in certain professions, forexample long haul truck drivers, to show that the device is being usedin compliance with the HCP's instructions. Some devices comprise anelectronic microchip that records the date and time the device was inuse and the date and time the device was not in use. The data from these“compliance chips” can then be downloaded and communicated with theinsurance company or another monitoring agency. In some embodiments,where such compliance chip is required or recommended, HCP chooses toinclude the chip in the splint design. The automated manufacturingmachine is then programmed to include a space for the chip. The chip canthen be inserted either automatedly or manually.

Following the overnight use of a mandibular advancement device, thejoints and muscles of the jaw may experience fatigue, spasms, and painbecause the mandible has been held in a forward, unnatural position forseveral hours. An AM positioner, or a morning positioner, for exampleGood Morning Positioner (Space Maintainers Laboratories, Chatsworth,Calif.) will assist to restore the jaw in the proper position. In someembodiments, the HCP chooses to provide additional instructions for thedesign of an AM positioner, in addition to the instructions for thesplint design, or independent of the splint design, as the same patientdata would be used in the manufacturing of both devices.

When a foreign device is inserted into the mouth, subconsciously themouth continues to explore the new device, leading to tongue fatigue,which in turn leads to the tongue falling back in the mouth and furtheraggravating or producing a sleep apnea condition. In addition, tongueexploration of the device can lead to more anterior tongue activity andprotrusions. An attractor can promote this even further to enhancetongue protrusion and increase muscle tone for a more viable airway. Bystrategically positioning a tongue attractor, e.g., a dent, a boss, aridged or rough surface, and the like, in the splint, the tongue seeksthe attractor and stays in position over the attractor, reducing oreliminating tongue fatigue, and/or enhanced tongue protrusion. In someembodiments, either the lower or upper, or both, splint has organicshapes as part of the design to increase the natural feel and comfort ofthe device, and to also activate the tongue via proprioceptive pathways,which cause the tongue and/or the muscle structure surrounding theairway respond to keep the airway open leading to a reduction in airwayrelated symptoms. In some embodiments, the tongue attractor is one ormore tori located in the anterior portion of the splint.

Individuals with bruxism, i.e., night-time teeth grinding, regularly areprescribed a bruxism package, which comprises a mouth guard that willprotect the teeth during the subconscious grinding. In some embodiments,where the patient suffers from bruxism in addition to sleep apnea, theHCP chooses to include a bruxism package with the splint design. In someembodiments, the bruxism package is designed from the same set ofpatient data provided from the HCP.

In some embodiments, the selection of certain embodiments of an optionrenders the selection of certain embodiments of another option moot. Forexample, if the HCP chooses to select Microtitration Series for thetitration mechanism, then the HCP will not be permitted to choose aHerbst hinge for the titration accessories. Instead, only accessoriesassociated with the Microtitration Series, for example fixed orremovable fins, will be available. The “smart” Rx allows onlycombinations of features such as the titration mechanism or any otherfeatures of the design that meet the clinical and engineeringrequirements of making a safe and useful device. Combinations for theselected features are presented visually to the HCP for verification oftheir selection.

Data Handling

Once all the selections are made on the website, the HCP communicatesthe selections with the MFG by any method currently known in the art, orlater developed, for sending data through a web portal, for example, byclicking on a “SEND” icon at the bottom of the page, and the like. Atthis point, the HCP may also transmit the data regarding the patient'sdentition impression to the laboratory as well. These data may includephotographs, scanning data files, and the like. In some embodiments, theHCP transmits the two sets of the data (selections and impression)simultaneously. In other embodiments, the HCP transmits one set of dataprior to the other set of data, for example, by transmitting each set ofdata shortly after it is obtained.

In some embodiments, the data is communicated electronically. In some ofthese embodiments, the HCP transmits the data files by electronic mail.In other embodiments, the HCP transmits the data files by uploading andtransmitting the files through a website. In some embodiments the datais incorporated into a 3D PDF, such as that provided by Adobe®(https://helpx.adobe.com/acrobat/using/displaying-3d-models-pdfs.html).

In some embodiments, a first HCP obtains the impression data and asecond, different, HCP prepares the selections. In some embodiments, thefirst and the second HCP are coworkers while in other embodiments, theyare not coworkers. In some embodiments, the same HCP who obtains theimpression data is the same individual as the HCP who prepares theselections.

As mentioned above, from the dentition impression data a design of thepatient's dentition is obtained, for example using CAD, by methodswell-known in the art. In other embodiments, the HCP prepares the designand transmits it to the MFG. In other embodiments, the MFG obtains theraw data from the HCP and prepares the design in-house.

In some embodiments, the HCP is in possession of all the patient dataand design specifications used to treat the patient. The HCP can thendraw conclusions and/or trends as to which design features are bestsuited for the treatment of which anomalies. In some embodiments, thedata from all the HCPs is aggregated in one database to obtain a moreaccurate design-efficacy relationship for each patient anomaly. Thisprocess is sometimes referred to as “phenotyping,” where a single orcombination of design specifications is correlated with the treatment ofa single malady. Whether aggregate data or single-HCP data us used, theresult would be a more efficient treatment plan for future patients.

Subsequently, the computerized design of a dental device is prepared,taking into account the HCP' s selections. The CAD file containing thedesign is then communicated to an automated manufacturing machine.

Manufacturing

The final stage of the process is the manufacture of the dental device.The CAD file containing the data related to the manufacture of thedental device is communicated with an automated manufacturing system.

In some embodiments, the appliance is manufactured additively, while inother embodiments, the appliance is manufactured subtractively. By“additive manufacturing” it is meant that the future device begins at anucleus and grows from the nucleus. Examples of additive manufacturinginclude 3D printing (where the device grows out of a pool of monomers),injection molding (where the mold is filled with the monomer). By“subtractive manufacturing” it is meant that the future device is carvedout of a block of material. Examples of subtractive manufacturinginclude hand carving and milling, e.g., an automated milling machine.

In some embodiments, depending on the type of selections made by theHCP, some clinical options, such as the Herbst lock or ball clasps, areincorporated into the device subsequent to the manufacturing step. Insome embodiments, these clinical options are added automatedly by eitherthe manufacturing device or another machine, while in other embodimentsthe clinical options are added manually. In some embodiments the deviceis the result of assembly of parts from both additive and subtractivemanufacturing. The fully manufactured device is then provided to thepatient either by the MFG or the HCP.

In some instances, the HCP may be unsure of what titration mechanismworks best for the patient, or that the patient may benefit fromdifferent types of titration mechanisms as the treatment progresses. Forexample, the HCP may require a Herbst mechanism for the initial stagesof the treatment, but would like to switch to a microtitration or astrap mechanism when the patient's mandibular position approaches thedesired location or for maintenance therapy. In these embodiments, thesplints are designed and manufactured with an attachment mechanism, suchas a ball-clasp system, friction lock, a nut for a screw-on attachment,and the like. One example of the attachment mechanism is disclosed inthe U.S. Pat. No. 9,615,964, incorporated by reference herein in itsentirety including the drawings. The splints and the attachments arethen manufactured separately. The HCP can then swap out the attachedmechanism for a different one as the needs of the patient change.

In another aspect, disclosed herein is a dental device that ismanufactured by the methods disclosed above.

In another aspect, disclosed herein is a method of treating orameliorating a jaw-related disorder in a patient by obtaining a dentaldevice manufactured by the methods disclosed above and positioning thedental device over the dentition prior to sleep. The device thenadvances the mandible forward relative to the maxilla, therebyameliorating the symptoms of sleep apnea or the jaw-related disorder. Insome embodiments, the method further comprises instructing the patientin the use of the device. In some embodiments, the jaw-related disorderis selected from temporomandibular disorder (TBD), poorly positionedtemporomandibular joint (TMJ), or aesthetic deficiencies.

What is claimed is:
 1. A method of manufacturing a kit, the kitcomprising a set of mandibular advancement devices, the methodcomprising: a. preparing a three-dimensional electronic model of thepatient's dentition; b. converting the electronic model to a data set;c. obtaining a set of clinical options, i.e., a prescription, from ahealth care provider (HCP) for the treatment of the patient, d.incorporating within a computer-aided design (CAD) software the data setand the set of clinical options; e. automatedly manufacturing a dentalappliance, having the set of clinical options, in accordance with theappliance data set; wherein: the set of mandibular advancement devicescomprise at least one upper and at least one lower splint; each upperand each lower splint independently comprises a fin, or a post for a finto attach thereto; each upper fin or post is located at a distance UDfrom the back of the upper splint, and each lower fin or post is locatedat a distance LD from the back of the lower splint; the distances UD andLD are independently unchangeable; f. providing a first spacer and asecond spacer, each spacer having a thickness, and each spacer having acontact surface; wherein: each spacer connects by a locking mechanism toone of the upper or lower fin, or one of the upper or lower post; thethickness of the first spacer is different than the thickness of thesecond spacer; when added, the spacer affords a rake angle of betweenabout 20° to about 80°, between about 80° to about 100°, or betweenabout 100° to about 160°.
 2. The device of claim 1, wherein the upperand lower splints are designed digitally and manufactured according tothe digital design.
 3. The device of claim 1, wherein each upper fincomprises a front surface and each spacer on a lower post comprises aback surface, wherein when the upper and lower splints are worn by apatient, the front surface of the upper fin contacts the back surface ofthe lower spacer along a contact surface; or
 4. The device of claim 1,wherein each spacer on an upper post comprises a front surface and eachlower fin comprises a back surface, wherein when the upper and lowersplints are worn by a patient, the front surface of the upper postcontacts the back surface of the lower fin along a contact surface. 5.The device of claim 1, wherein the shape of each or spacer isindependently selected from a predesigned digital library.
 6. The deviceof claim 1, wherein the spacer comprises a locking mechanism.
 7. Thedevice of claim 6, wherein the locking mechanism is a friction lockmechanism or a key-tab mechanism.
 8. The device of claim 1, wherein theset of clinical options comprises two or more clinical options selectedfrom the group consisting of titration mechanisms, titrationaccessories, splint design, retention mechanisms, splint material, andfin or strap design or sleeve.
 9. The device of claim 8, wherein thetitration mechanism is selected from the group consisting ofmicrotitration series, jack screw titration, Herbst hinge titration,anterior hinge titration, strap titration, and mechanical hook.
 10. Thedevice of claim 8, wherein the splint material option is selected fromthe group consisting of standard polymethylmethacrylate (PMMA), linedPMMA, high-strength polyetheretherketone (PEEK), polymer produced frompolyoxymethylene and acetal copolymers (Duracetal®), glycol modifiedpolyethylene terephthalate (PETg), and a physiologically compatible,water insoluble, non-maleable polymer.
 11. A kit manufactured by themethod of claim
 1. 12. A kit comprising: a) a set of mandibularadvancement devices comprising at least one upper and at least one lowersplint; each upper and each lower splint independently comprises a fin,or a post for a fin to attach thereto; each upper fin or post is locatedat a distance UD from the back of the upper splint, and each lower finor post is located at a distance LD from the back of the lower splint;the distances UD and LD are independently unchangeable; and b) atplurality of spacers, each spacer having a thickness, and each spacerhaving a contact surface; wherein: each spacer connects by a lockingmechanism to one of the upper or lower fin, or one of the upper or lowerpost; the thickness of each spacer is different than the thickness ofany other spacer of the plurality of spacers; when added, the spaceraffords a rake angle of between about 20° to about 80°, between about80° to about 100°, or between about 100° to about 160°.